Bipolar DisorderNCT00181831
Spectroscopy in Children and Adolescents With Bipolar Disorder
An observational study of Bipolar Disorder and ADHD, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, ADHD
- What is being tested?
- Proton Magnetic Resonance Spectroscopy
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone.
Who may be able to join
- Male or female subjects, 6-17 years of age
- Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol
- Subjects and their legal representatives must be considered reliable
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
- Bipolar subjects must have a diagnosis of bipolar I or bipolar II disorder with a lifetime manic or mixed episode (with or without psychotic features) according to the DSM-IV confirmed by structured diagnostic interview (KSADS)
- ADHD subjects must meet full criteria for ADHD (with or without hyperactivity) according to the DSM-IV confirmed by structured diagnostic interview (KSADS)
Who cannot join
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Pregnant of nursing females
- Presence of metal or surgical devices (aneurysm clips, metal plates, cochlear implants, neurostimulators, braces, and other items) in vital areas.
- Severe phobia of being in small, enclosed spaces (claustrophobic)
- Bipolar subjects must either have been free of antipsychotic medication (including risperidone) for 3 months of longer OR be currently treated with risperidone for 8 weeks or longer.
- ADHD subjects must not meet criteria for bipolar disorder by structured interview (KSADS). These subjects must be free of antipsychotic medication for 3 months or longer).
- Control subjects must not meet criteria for ADHD or bipolar disorder by structured interview (KSADS). These subjects must be free of antipsychotic medication treatment for 3 months or longer.
- Left hand dominant subjects will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Proton Magnetic Resonance Spectroscopy in Children and Adolescents With Bipolar Disorder
The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone. For comparison, results will also be obtained from 20 controls (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior cingular gyrus will be lower in subjects who have received eight weeks or longer of risperidone
Read the detailed description
Choline containing compound (Cho) and creatine + phosphocreatine (Cr) have been found to be greater in the orbitofrontal cortex of depressed adolescents. In addition, Cho/Cr has been found to increase in the anterior cingulate in depressed patients with bipolar affective disorder (BPD) compared with comparison subjects. Also, BPD subjects not taking antidepressants had a significantly higher anterior cingulate Cho/Cr compared with subjects taking antidepressants or comparison subjects. Therefore it would appear the frontal lobe Cho/Cr is increased in depression. Given these findings, we are interested in looking at subjects with mania to investigate if there may also be a biological marker for mania and drug response. Mania measured using the YMRS have been associated with an increase in the anterior cingulate Ino/Cr in manic children, adolescents, and adults with bipolar affective disorder. In addition, children and adolescents who were responsive to lithium showed a decrease in Ino/Cr levels after acute lithium treatment. We will test whether Ino/Cr levels will correlate positively with manic symptoms using the YMRS, as well as whether overall Ino/Cr levels will be lower for children and adolescents receiving risperidone.
The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone. For comparison, results will also be obtained from 20 controls (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior cingular gyrus will be lower in subjects who have received eight weeks or longer of risperidone
- Conditions
- Bipolar Disorder, ADHD
- Being tested
- Proton Magnetic Resonance Spectroscopy
- Keywords
- SPECT, bipolar disorder, ADHD, children
- Medical subject headings
- Bipolar Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Magnetic Resonance SpectroscopyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181831
- Sponsor's protocol ID
- 2002-P-000661
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Magnetic Resonance Spectroscopy in Children and Adolescents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00181831
- Acronym / sponsor ID
- 2002-P-000661
- Conditions
- Bipolar Disorder, ADHD
- Keywords
- SPECT, bipolar disorder, ADHD, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Study start
- Dec 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone. For comparison, results will also be obtained from 20 controls (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior cingular gyrus will be lower in subjects who have received eight weeks or longer of risperidone
Detailed description
Choline containing compound (Cho) and creatine + phosphocreatine (Cr) have been found to be greater in the orbitofrontal cortex of depressed adolescents. In addition, Cho/Cr has been found to increase in the anterior cingulate in depressed patients with bipolar affective disorder (BPD) compared with comparison subjects. Also, BPD subjects not taking antidepressants had a significantly higher anterior cingulate Cho/Cr compared with subjects taking antidepressants or comparison subjects. Therefore it would appear the frontal lobe Cho/Cr is increased in depression. Given these findings, we are interested in looking at subjects with mania to investigate if there may also be a biological marker for mania and drug response. Mania measured using the YMRS have been associated with an increase in the anterior cingulate Ino/Cr in manic children, adolescents, and adults with bipolar affective disorder. In addition, children and adolescents who were responsive to lithium showed a decrease in Ino/Cr levels after acute lithium treatment. We will test whether Ino/Cr levels will correlate positively with manic symptoms using the YMRS, as well as whether overall Ino/Cr levels will be lower for children and adolescents receiving risperidone.
The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone. For comparison, results will also be obtained from 20 controls (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior cingular gyrus will be lower in subjects who have received eight weeks or longer of risperidone
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone.
Key inclusion criteria (6 listed)
- Male or female subjects, 6-17 years of age
- Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol
- Subjects and their legal representatives must be considered reliable
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
- Bipolar subjects must have a diagnosis of bipolar I or bipolar II disorder with a lifetime manic or mixed episode (with or without psychotic features) according to the DSM-IV confirmed by structured diagnostic interview (KSADS)
Key exclusion criteria (8 listed)
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Pregnant of nursing females
- Presence of metal or surgical devices (aneurysm clips, metal plates, cochlear implants, neurostimulators, braces, and other items) in vital areas.
- Severe phobia of being in small, enclosed spaces (claustrophobic)
- Bipolar subjects must either have been free of antipsychotic medication (including risperidone) for 3 months of longer OR be currently treated with risperidone for 8 weeks or longer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Magnetic Resonance Spectroscopy | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and ADHD, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.